Senior Clinical Data Associate
About the position
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. This position reports to the Associate Director, Clinical Data Management, Oncology and is part of the Oncology Data Management organization, which supports Sumitomo Pharma America’s clinical development programs by ensuring accurate, complete, and compliant clinical trial data. The Senior Clinical Data Associate (Sr. CDA) works in close partnership with Lead/Clinical Data Managers (LDM/CDM) and supports multiple oncology studies with increased independence and accountability. The role contributes directly to data quality, timeline adherence, and inspection readiness while collaborating closely with Clinical Operations, Safety, Biostatistics, and external vendors.
Responsibilities
• Perform end to end clinical data review activities, including query generation, review, follow up, and closure, in accordance with study specific guidelines and timelines.
• Conduct in house data review and provide detailed feedback to the Lead/Clinical Data Manager or CRO Data Management team.
• Support eCRF design, system validation activities, and ongoing EDC updates in collaboration with external vendors.
• Assist in the development, review, and maintenance of Data Management documentation, including: Data Management Plans (DMPs) CRF Completion Guidelines Data Validation Specifications / edit checks Data Cleaning and Reconciliation Plans
• Perform reconciliation activities (e.g., SAE reconciliation), raise and track associated queries, and escalate potential issues to Safety and Data Management leadership.
• Support interim analysis and database lock activities, including focused data cleaning and reconciliation deliverables.
• Support management of Lab Normal Ranges for studies with Local Labs.
• Provide data management status updates to internal study teams in the absence of the Lead/Clinical Data Manager.
• Take ownership of defined data management tasks or act as the primary Data Management contact for selected projects or study components.
• Train and mentor junior Clinical Data Associates on assigned tasks and Data Management procedures.
• Ensure strict adherence to Data Management standards, SOPs, and applicable regulatory requirements.
• Perform other assigned duties in support of departmental objectives.
Requirements
• Solid understanding of clinical data management processes and clinical trial conduct under ICH/GCP.
• Hands‑on experience with EDC systems, query management, data cleaning, and reconciliation workflows.
• Strong attention to detail and ability to manage competing priorities across multiple studies.
• Ability to work independently with minimal supervision while knowing when to escalate issues.
• Effective written and verbal communication skills.
• Strong collaboration skills in a matrixed, cross‑functional environment.
• Demonstrated ability to mentor junior team members and share best practices.
• Bachelor’s degree in life sciences or a related field required.
• Minimum 3 years of clinical data management experience in the pharmaceutical or biotech industry.
• Ability to travel.
Nice-to-haves
• Oncology experience preferred.
Benefits
• merit-based salary increases
• short incentive plan participation
• eligibility for our 401(k) plan
• medical, dental, vision, life and disability insurances
• leaves provided in line with your work state
• flexible paid time off
• 11 paid holidays
• additional time off for a shut-down period during the last week of December
• 80 hours of paid sick time upon hire and each year thereafter
Apply tot his job
Apply To this Job
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. This position reports to the Associate Director, Clinical Data Management, Oncology and is part of the Oncology Data Management organization, which supports Sumitomo Pharma America’s clinical development programs by ensuring accurate, complete, and compliant clinical trial data. The Senior Clinical Data Associate (Sr. CDA) works in close partnership with Lead/Clinical Data Managers (LDM/CDM) and supports multiple oncology studies with increased independence and accountability. The role contributes directly to data quality, timeline adherence, and inspection readiness while collaborating closely with Clinical Operations, Safety, Biostatistics, and external vendors.
Responsibilities
• Perform end to end clinical data review activities, including query generation, review, follow up, and closure, in accordance with study specific guidelines and timelines.
• Conduct in house data review and provide detailed feedback to the Lead/Clinical Data Manager or CRO Data Management team.
• Support eCRF design, system validation activities, and ongoing EDC updates in collaboration with external vendors.
• Assist in the development, review, and maintenance of Data Management documentation, including: Data Management Plans (DMPs) CRF Completion Guidelines Data Validation Specifications / edit checks Data Cleaning and Reconciliation Plans
• Perform reconciliation activities (e.g., SAE reconciliation), raise and track associated queries, and escalate potential issues to Safety and Data Management leadership.
• Support interim analysis and database lock activities, including focused data cleaning and reconciliation deliverables.
• Support management of Lab Normal Ranges for studies with Local Labs.
• Provide data management status updates to internal study teams in the absence of the Lead/Clinical Data Manager.
• Take ownership of defined data management tasks or act as the primary Data Management contact for selected projects or study components.
• Train and mentor junior Clinical Data Associates on assigned tasks and Data Management procedures.
• Ensure strict adherence to Data Management standards, SOPs, and applicable regulatory requirements.
• Perform other assigned duties in support of departmental objectives.
Requirements
• Solid understanding of clinical data management processes and clinical trial conduct under ICH/GCP.
• Hands‑on experience with EDC systems, query management, data cleaning, and reconciliation workflows.
• Strong attention to detail and ability to manage competing priorities across multiple studies.
• Ability to work independently with minimal supervision while knowing when to escalate issues.
• Effective written and verbal communication skills.
• Strong collaboration skills in a matrixed, cross‑functional environment.
• Demonstrated ability to mentor junior team members and share best practices.
• Bachelor’s degree in life sciences or a related field required.
• Minimum 3 years of clinical data management experience in the pharmaceutical or biotech industry.
• Ability to travel.
Nice-to-haves
• Oncology experience preferred.
Benefits
• merit-based salary increases
• short incentive plan participation
• eligibility for our 401(k) plan
• medical, dental, vision, life and disability insurances
• leaves provided in line with your work state
• flexible paid time off
• 11 paid holidays
• additional time off for a shut-down period during the last week of December
• 80 hours of paid sick time upon hire and each year thereafter
Apply tot his job
Apply To this Job